Regulatory Affairs Specialist I
About The Position
Laborie Medical Technologies is currently searching for a Regulatory Affairs Specialist to join our team in hybrid role based out of the Portsmouth, NH or Minnetonka, MN offices. The Regulatory Affairs Specialist will support global product registration, approval, and lifecycle maintenance activities across key markets, including the United States, Canada, Europe, and other international regions. This role is responsible for ensuring that regulatory approvals are obtained, maintained, and renewed in accordance with applicable regulatory requirements and internal standards. The individual will contribute to regulatory strategy and execution for assigned product lines, including preparing and submitting regulatory submissions, managing product registrations and renewals, and ensuring ongoing compliance with global regulatory requirements. The Regulatory Affairs Specialist will work cross-functionally to support product changes, maintain regulatory documentation, and ensure alignment with established corporate procedures and quality standards.
Requirements
- Bachelor’s degree in Science, Engineering, or other relevant discipline
- 1-3 years' experience in Regulatory Affairs in the medical device industry
- 1-3 years' experience in international registrations
- Working knowledge of quality system regulations and guidelines
- Great communication skills with all levels of personnel
- High level of organization and planning skills
- Working knowledge of medical devices, procedures, and terminology
Responsibilities
- Preparing and submitting documentation necessary for regulatory approval of assigned products.
- Defining worldwide regulatory requirements necessary for regulatory approval of assigned products, and advising cross-functional teams on regulatory strategies.
- Executing product submission strategies as directed.
- Maintaining all regulatory documentation to ensure availability for external audits and preparation of submission packages.
- Maintaining a thorough knowledge of current regulatory requirements.
- Executing on additional responsibilities as defined by management.
Benefits
- Paid time off
- paid volunteer time
- Medical, Dental, Vision and Flexible Spending Account
- Health Savings Account with Company Funded Contributions
- 401k Retirement Plan with Company Match
- Parental Leave and Adoption Services
- Health and Wellness Programs and Events
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
